Efficacy of Pragmatic Same-day COVID-19 Ring Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland

Calmy Alexandra326 enrolled

Overview

A study to assess, in a two-arm open-label cluster randomized clinical trial, the efficacy of a 5-day course of LPV/r treatment in preventing COVID-19 in asymptomatic individuals exposed to a SARS-CoV-2 documented index patient, compared to surveillance alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

326

Conditions

Prevention of COVID-19

Interventions

Lopinavir/ritonavirDRUG

2x 200mg/50mg, twice daily for 5 days (bid, PO)

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Documented close contact with a person with either a PCR-confirmed SARS-CoV-2 or a positive rapid SARS-CoV-2 antigen test (as per standard of care). 2. Enrolment of the participant no more than 7 days since last contact with index case; 3. ≥ 16 years of age; 4. Informed consent as documented by signature (including parent's or legal guardian's signature if the participant is between 16 and 18 y.o.). Exclusion criteria\*: 1. Fever (temperature \>38.0°C) and/or respiratory symptoms (cough, dyspnea) and/or new anosmia/ageusia; 2. Individuals with previous confirmed SARS-CoV-2 infection, dating within the last six months ; 3. Known impairment of liver function; 4. Known hypersensitivity to the study medications; 5. Use of any medications that are contraindicated with lopinavir/ritonavir using the website www.hiv-druginteractions.org/checker 6. Individuals on boosted protease inhibitor (other than LPV) or boosted elvitegravir as part of an antiretroviral therapy 7. Inability to be followed-up for the trial period 8. Documented vaccination against SARS-CoV-2 * Where necessary, additional biological and clinical assessment will be performed, based on clinical judgement.

Locations (4)

Instituto Nacional de Infectiologia Evandro Chagas, Fiocruz

Rio de Janeiro, Brazil

Universitätsspital Basel and SwissTPH

Basel, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Ospedale Regionale di Lugano

Lugano, Switzerland

Outcomes

Primary Outcomes

21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis).

Time frame: 21-day

Secondary Outcomes

21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT)

Time frame: 21-day

21-day incidence of SARS-CoV-2 infection in individuals exposed to SARS-CoV-2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT)

Time frame: 21-day

Severity of clinical COVID-19 on a 7-point ordinal scale

(1: not hospitalized, no limitations on activities, 2: not hospitalized, limitation on activities, 3: hospitalized, not requiring supplemental oxygen, 4: hospitalized, requiring supplemental oxygen, 5: hospitalized, on non- invasive mechanical ventilation 6: hospitalized, on invasive mechanical ventilation or ECMO and 7: death)

Time frame: 21-day

Data from ClinicalTrials.gov

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